Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome (SQUIDperi Study)

Pelvic Bleeding Clinical Trial

— SQUIDperi  

Official title:

A France-based Study for Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome: SQUIDperi Study: A Non-interventional, Prospective, Single-arm, Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04787120
• Other study ID #: LOFFROY BALT 2020-1
• Status: Not yet recruiting
• Start date: April 1, 2021
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Romaric LOFFROY
• Phone: 03 80 29 33 58
• Email: romaric.loffroy[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx.

During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today.

The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: March 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient presenting with an arterial abdominopelvic bleeding or imminent risk of bleeding, including visceral, muscular or GI territories, requiring embolization, along with angiographic abnormalities

• Patient for whom the use of SQUIDperi had been decided for an embolization

• Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access

• Patient > 18 years

Exclusion Criteria:

• Patient with severe live failure

• Patient participating in another interventional study

• Vulnerable patients including pregnant women

• Patient not eligible for treatment with liquid embolic agent

• Patients presenting contra-indications to SQUIDperi as describes in the Informations For Use (IFU)

Related Conditions & MeSH terms

• Abdominal
• Arterial Bleed
• Embolism
• Embolism Arterial
• Hemorrhage
• Pelvic Bleeding

Intervention

Device:
• SQUIDperi
Liquid embolic delivery syringes and micro-catheter

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of embolization success at one month	Defined as the absence of re-intervention for re-bleeding from the target artery/arteries embolized during the index procedure	1 month